US FDA Granted Orphan Drug Designation to Neuren's NNZ-2591 drug

  • Oct 16, 2019 AEDT
  • Team Kalkine

The Federal agency of the United States Department of Health and Human Services, US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren Pharmaceuticals’ (ASX: NEU) NNZ-2591.

  • Neuren’s NNZ-2591 drug is used in the treatment of each of Phelan-McDermid syndrome and Pitt Hopkins syndrome;
  • Orphan Drug designation is a special status that the FDA may grant to a drug to treat a rare disease or condition;
  • Orphan Drug designation qualifies the sponsor of the drug for 7 years of marketing exclusivity, plus 6 months if approved for pediatric use.

By AEST 1:12 PM, NEU’s stock was trading at $2.470, up by 2.917% on previous close.


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